Description

Naproxen is a NSAID with analgesic and antipyretic properties. The mechanism of action of Naproxen is like that of other NSAIDs, related to prostaglandin synthetase inhibition. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Presentation

    Neso Tablet (375 mg/20 mg): Each enteric coated tablet contains Naproxen BP 375 mg & Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
    Neso Tablet (500 mg/20 mg): Each enteric coated tablet contains Naproxen BP 500 mg & Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.

Indications

    Neso Tablet is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAIDs-associated gastric ulcers.

Dosage & Administration

    The dosage is one tablet twice daily of Neso 375 mg Naproxen and 20 mg of Esomeprazole or 500 mg Naproxen and 20 mg of Esomeprazole. Neso is to be taken at least 30 minutes before meals.

Contrainidications

    This combination is contraindicated in patients with known hypersensitivity to Naproxen, Esomeprazole Magnesium or to any of the excipients. This combination is contraindicated in patients who have experienced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs. This combination is also contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery and in patients in the late stage of pregnancy.

Warning & Precautions

Side effects

    The adverse effects reported with this combination may include gastrointestinal disorders like dyspepsia, diarrhea, nausea, flatulence, abdominal pain etc.

Drug interaction

    Several studies have shown no interaction between the two components Naproxen and Esomeprazole. NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. Probenecid increases Naproxen anion plasma levels and extends its plasma half-life significantly. Co-administration of oral contraceptives, diazepam, phenytoin or quinidine does not seem to change the pharmacokinetic profile of Esomeprazole.

Use in special groups

    Use in pregnancy: Naproxen & Esomeprazole both are pregnancy category B drug. This combination should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Use in nursing mothers: Naproxen & Esomeprazole are likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

    Use in pediatric patients: Naproxen: The safety and efficacy of Naproxen in pediatric patients below the age of 2 years have not been established. Esomeprazole: Children over 1 year are recommended to use oral Esomeprazole.

    Use in geriatric patients: Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients.

    Use in hepatic Insufficiency: This combination is not recommended for use in patients with severe hepatic impairment because Esomeprazole doses should not exceed 20 mg daily in these patients.

    Use in renal Insufficiency: This combination is not recommended for use in patients with advanced renal disease (creatinine clearance < 30 mL/min).

Packing

    Neso Tablet (375 mg/20 mg): Each box contains 50 tablets in Alu-Alu blister pack.
    Neso Tablet (500 mg/20 mg): Each box contains 50 tablets in Alu-Alu blister pack.